Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1ACIC Fine Chemicals
03 2Cambrex Corporation
04 1Lupin Ltd
05 1Maithri Drugs
06 1Recordati
07 1Blank
01 5CYSTEAMINE BITARTRATE
02 1CYSTEAMINE BITARTRATE (MONOHYDRATE)
03 1CYSTEAMINE BITARTRATE (RP)
04 1PHOSPHOCYSTEAMINE
01 3India
02 1Italy
03 3U.S.A
04 1Blank
01 7Active
02 1Inactive
01 2Complete
02 6Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37094
Submission : 2022-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-26
Pay. Date : 2013-09-06
DMF Number : 26816
Submission : 2013-09-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9619
Submission : 1992-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27574
Submission : 2013-07-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-23
Pay. Date : 2019-09-12
DMF Number : 32668
Submission : 2018-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35758
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38209
Submission : 2023-04-17
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7405
Submission : 1988-03-26
Status : Inactive
Type : II
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A Cysteamine Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteamine Bitartrate, including repackagers and relabelers. The FDA regulates Cysteamine Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteamine Bitartrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cysteamine Bitartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cysteamine Bitartrate supplier is an individual or a company that provides Cysteamine Bitartrate active pharmaceutical ingredient (API) or Cysteamine Bitartrate finished formulations upon request. The Cysteamine Bitartrate suppliers may include Cysteamine Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Cysteamine Bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cysteamine Bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cysteamine Bitartrate active pharmaceutical ingredient (API) in detail. Different forms of Cysteamine Bitartrate DMFs exist exist since differing nations have different regulations, such as Cysteamine Bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cysteamine Bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Cysteamine Bitartrate USDMF includes data on Cysteamine Bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cysteamine Bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cysteamine Bitartrate suppliers with USDMF on PharmaCompass.
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